Events

Retiro De Equipo (Recall) de Device Recall VKS Knee System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Plus Orthopedics USA.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    34255
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0397-06
  • Fecha de inicio del evento
    2005-12-02
  • Fecha de publicación del evento
    2006-01-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43345
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
  • Causa
    The adjustment knob tower on one device was found to have broken off from the body of the instrument. this did not happend during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. a manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.
  • Acción
    The adjustment know tower on one device was found t have broken off from the body of the instrument. This did not happend during a surgery, and is belived tohave been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.

Device

Device Recall VKS Knee System
  • Modelo / Serial
    PI.79;  PI.79/I;  PI.79/IIII;  PI.80;  PI.80/III;  PI.80/IIII;  PI.80/IIIII
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Arizona, California, Colorado, Idaho, New York, Oklahoma, Texas, Utah, Wisconsin
  • Descripción del producto
    VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)
  • Manufacturer
    Plus Orthopedics USA

Manufacturer

Plus Orthopedics USA
  • Dirección del fabricante
    Plus Orthopedics USA, 10188 Telesis Ct, San Diego CA 92121-4779
  • Source
    USFDA